The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients

Conditions

• Arrythmia
• Cardiomyopathies

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intra-Op Prophylactic VT ablation — PROCEDURE
  For surgical intra-operative ablation, efforts will be made to identify scarred myocardium based on methods such as cardiac magnetic resonance imaging, nuclear scans, and/or echocardiogram. Electrophysiological mapping may be obtained either pre-surgery or intra-operation. Mapping and ablation will be performed with the currently approved and updated mapping and ablation systems available at each center. Voltage mapping of the ventricle(s) to delineate scars will be carried out through electroanatomic mapping
• Conventional Management — OTHER
  To ensure uniformity in control arm, a standardized AAD regimen is recommended among subjects randomized to the medical management control arm. Subjects who are already on a stable AAD regimen, such as amiodarone, sotalol or dofetilide, these should be continued

Study Details

To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery

Key Dates

Start date

May 27, 2022

Status verified

Mar 2026

Primary completion

Apr 30, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Intra-Op Prophylactic VT ablation
  Subjects will get ablation procedure as needed if they were determined to be refractory to medical antiarrhythmic control should undergo catheter-based electrophysiology study and ablation on LVAD support
• Active Comparator: Conventional Management
  To ensure uniformity in control arm, a standardized AAD regimen is recommended among subjects randomized to the medical management control arm. Subjects who are already on a stable AAD regimen, such as amiodarone, sotalol or dofetilide, these should be continued

Primary Outcome Measure

Recurrent VTA [ Time Frame: Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months) ]

Central Contacts

• Ann Colasurdo
  585-275-1054
  [email protected]
• Kathy Honsinger
  585-273-1899

Locations (19)

Find similar trials in Phoenix, AZ

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